Device Classification Name |
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
|
510(k) Number |
K163308 |
Device Name |
SMARTO |
Applicant |
JEIL MEDICAL CORPORATION |
SEOUL,
KR
152-728
|
|
Applicant Contact |
JAEHAN PARK |
Correspondent |
JEIL MEDICAL CORPORATION |
SEOUL,
KR
152-728
|
|
Correspondent Contact |
JAEHAN PARK |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 11/23/2016 |
Decision Date | 12/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|